Dabigatran Etexilate in Patients With Mechanical Heart Valves (RE-ALIGN)

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim
ClinicalTrials.gov Identifier:
NCT01452347
First received: October 11, 2011
Last updated: August 29, 2013
Last verified: August 2013
  Purpose

To validate the dosing algorithm for dabigatran etexilate in patients receiving a mechanical heart valve.


Condition Intervention Phase
Heart Valve Diseases
Drug: warfarin 1mg
Drug: dabigatran etexilate intermediate dose
Drug: dabigatran etexilate low dose
Drug: warfarin 5mg
Drug: dabigatran etexilate high dose
Drug: warfarin 3mg
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Randomised, Phase II Study to Evaluate the sAfety and Pharmacokinetics of oraL dabIGatran Etexilate in Patients After Heart Valve replacemeNt

Resource links provided by NLM:


Further study details as provided by Boehringer Ingelheim:

Primary Outcome Measures:
  • Total dabigatran concentration at trough [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 252
Study Start Date: October 2011
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dabigatran etexilate
Patient dose dependent on screening CrCl levels and TT
Drug: dabigatran etexilate intermediate dose
active treatment (medium)
Drug: dabigatran etexilate low dose
active treatment (low)
Drug: dabigatran etexilate high dose
active treatment (high)
Active Comparator: warfarin
warfarin doses to maintain INR levels
Drug: warfarin 1mg
comparator warfarin
Drug: warfarin 5mg
comparator warfarin
Drug: warfarin 3mg
comparator warfarin

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  1. Patients aged 18-75
  2. Patients who have received a bileaflet mechanical heart valve

Exclusion criteria:

  1. Prior valve surgery
  2. Uncontrolled hypertension
  3. severe renal impairment
  4. active liver disease
  5. increased risk of bleeding
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01452347

  Show 40 Study Locations
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
  More Information

Additional Information:
No publications provided by Boehringer Ingelheim

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT01452347     History of Changes
Other Study ID Numbers: 1160.113, 2010-022685-27
Study First Received: October 11, 2011
Last Updated: August 29, 2013
Health Authority: Belgium: Federal Agency for Medicinal and Health Products
Canada: Health Canada
Czech Republic: State Institute for Drug Control
Denmark: Danish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Netherlands: Central Committee Research Involving Human Subjects
Norway: Norwegian Medicines Agency
Poland: Registration Medicinal Product Medical Device Biocidal Product
Sweden: Medical Products Agency
United States: Food and Drug Administration

Additional relevant MeSH terms:
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Dabigatran
Warfarin
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 01, 2014